Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

INTRODUCTION: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. METHODS AND ANALYSIS: The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. RESULTS: Outcome will be published in a scientific journal. TRIAL REGISTRATION NUMBER: NTR5374; Pre-results.

The need for a standardized informed consent procedure in live donor nephrectomy: a systematic review.

BACKGROUND: Informed consent in live donor nephrectomy is a topic of great interest. Safety and transparency are key items increasingly getting more attention from media and healthcare inspection. Because live donors are not patients, but healthy individuals undergoing elective interventions, they justly insist on optimal conditions and guaranteed safety. Although transplant professionals agree that consent should be voluntary, free of coercion, and fully informed, there is no consensus on which information should be provided, and how the donors' comprehension should be ascertained. METHODS: Comprehensive searches were conducted in Embase, Medline OvidSP, Web-of-Science, PubMed, CENTRAL (The Cochrane Library 2014, issue 1) and Google Scholar, evaluating the informed consent procedure for live kidney donation. The methodology was in accordance with the Cochrane Handbook for Interventional Systematic Reviews and written based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RESULTS: The initial search yielded 1,009 hits from which 21 articles fell within the scope of this study. Procedures vary greatly between centers, and transplant professionals vary in the information they disclose. Although research has demonstrated that donors often make their decision based on moral reasoning rather than balancing risks and benefits, providing them with accurate, uniform information remains crucial because donors report feeling misinformed about or unprepared for donation. Although a standardized procedure may not provide the ultimate solution, it is vital to minimize differences in live donor education between transplant centers. CONCLUSION: There is a definite need for a guideline on how to provide information and obtain informed consent from live kidney donors to assist the transplant community in optimally preparing potential donors.

Regulatory failure contributing to deaths of live kidney donors.

Hemorrhagic deaths of living kidney donors from failure of vascular clips used on the renal artery, first documented in 2006, have continued due to postoperative Hem-o-lok clip failure with sudden, massive bleeding. While the FDA issued a Class II recall of the Hem-o-lok clip for laparoscopic donor nephrectomies in 2006, two live kidney donors in the United States and one in India have since died. Compliance in timely reporting of deaths by the manufacturer and donor hospitals has not been enforced. Oversight agencies did not inform practitioners that donors died due to clip failures. A February 2011 survey disclosed that Hem-o-lok or other clips are still used by some surgeons as a sole means of arterial control in laparoscopic donor nephrectomy; thus, a practice with documented fatal outcomes persists. We conclude that systems failures by oversight-regulatory agencies in communication to active clinicians led, at least in part, to preventable deaths. Information which was disseminated was neither complete nor timely. A corrective plan, funded by oversight agencies and the Hem-o-lok manufacturer, is proposed. All surgeons operating on a living organ donor must select vascular control techniques that entail tissue transfixion and assure a safe operative recovery. The Hem-o-lok and other surgical clips must not be used to control the donor renal artery.

Ethical issues with nondirected ("good samaritan") kidney donation for transplantation.

"Good samaritan" donation has been of great interest in Italy. At the request of the Presidency of the Council of Ministers, the National Committee on Bioethics expressed its opinion on the matter. While highlighting its controversial aspects, the assessment was favorable. The National Council for Health established working criteria. Yet eminent bioethicists sharing the same values have reached discordant conclusions. Legal developments leading to the authorization of living donor kidney transplants from blood relatives or emotionally close individuals may offer a path for ethical assessment of the practice.

Paired kidney donations to expand the living donor pool.

INTRODUCTION: The shortage of available deceased donors and the longer kidney transplant waiting lists in many countries around the world have placed greater emphasis on living donation (LD) as a means of meeting demand for transplantation in patients with end-stage kidney disease (ESKD). METHODS AND RESULTS: Increased LD rates are also driven by less invasive approaches to donor nephrectomy and by the excellent long-term results. LD kidney transplant outcomes are equivalent, if not superior, to those from deceased donors, even when donor and recipient are not genetically related, as is the case with spousal donations, the most frequent cohort of LD. Approximately 30% of willing and otherwise appropriate kidney donor/recipient pairs are biologically incompatible and do not proceed to live donor transplantation. In recent years, a number of strategies have been introduced to expand living donation programs beyond the classical direct donation, to overcome immunological barriers of blood group or HLA sensitization of recipients. New strategies in LD include paired kidney exchange (PKE), altruistic donation, altruistic donor chains and list exchange programs. Other alternative programs are desensitization and transplantation across the blood-type barrier. Regular PKE programs operate nationally in The Netherlands and the United Kingdom, or regionally in South Korea, Romania, the United States and Australia. CONCLUSIONS: If PKE were performed routinely using 2-way or 3-way PKE and altruistic donor chains, the rate of kidney transplants could increase by between 7% and 10%.